Key Points Question What is the recommended dose of difelikefalin, a κ-opioid receptor agonist, in Japanese patients with moderate to severe pruritus receiving hemodialysis? Findings In this phase 2 randomized… Click to show full abstract
Key Points Question What is the recommended dose of difelikefalin, a κ-opioid receptor agonist, in Japanese patients with moderate to severe pruritus receiving hemodialysis? Findings In this phase 2 randomized clinical trial of 247 patients, 8-week treatment with difelikefalin (0.5 or 1.0 μg/kg) significantly reduced pruritus according to the Numerical Rating Scale score for itch without any safety concerns. Meaning Difelikefalin at a dose of 0.5 μg/kg is expected to be a new option with high adherence, safety, and tolerability in the treatment of moderate to severe pruritus for patients receiving hemodialysis.
               
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